Cellcept

"The US Food and Drug Administration (FDA) has approved soluble ferric pyrophosphate (Triferic, Rockwell Medical) to replace iron and maintain hemoglobin in adults with chronic kidney disease who are undergoing dialysis.

For Patients

CellCept (mycophenolate mofetil) is an immunosuppressive agent used to prevent your body from rejecting a kidney, liver, or heart transplant. CellCept is usually given with cyclosporine (Sandimmune, Neoral) and a steroid medication. CellCept is available in generic form. Common side effects of CellCept include constipation, nausea, headache, diarrhea, vomiting, stomach pain or upset, loss of appetite, gas, tremor, trouble sleeping (insomnia), weakness, swelling in your hands or feet, numbness or tingly feeling, or anxiety.

The dose of CellCept depends on the type of transplant performed. CellCept may interact with cholestyramine, antibiotics, acyclovir, ganciclovir, valacyclovir, or other medicines that weaken the immune system. Tell your doctor all medications you use. CellCept is not recommended for use during pregnancy because of possible harm to the fetus. Women of childbearing age should have a negative pregnancy test within 1 week of starting this medication. Use two forms of birth control starting 4 weeks before beginning therapy, and continue for at least 6 weeks after the drug is stopped. Consult your doctor. It is unknown if this drug passes into breast milk, but it may have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug and for 6 weeks after stopping it. Consult your doctor for details.

Our CellCept (mycophenolate mofetil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Because this medication weakens your immune system, you are more likely to develop infections which may be serious. Tell your doctor immediately if you develop any of the following signs of infection: persistent sore throat/fever, night sweats, flu-like symptoms, painful urination, vision changes, a sore or wound on the skin that feels warm/tender/painful and appears reddened.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, fast/irregular heartbeat, muscle weakness, easy bleeding/bruising, swelling of the feet or ankles, mental/mood changes, weakness on one side of the body, unusual change in the amount of urine.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds, shortness of breath/rapid breathing.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

The principal adverse reactions associated with the
administration of CellCept include diarrhea, leukopenia, sepsis, vomiting, and
there is evidence of a higher frequency of certain types of infections eg,
opportunistic infection (see WARNINGS: Serious Infections and WARNINGS:
New or Reactivated Viral Infections). The adverse event profile
associated with the administration of CellCept Intravenous has been shown to be
similar to that observed after administration of oral dosage forms of CellCept.

Safety data are summarized below for all
active-controlled trials in renal (2 trials), cardiac (1 trial), and hepatic (1
trial) transplant patients. Approximately 53% of the renal patients, 65% of the
cardiac patients, and 48% of the hepatic patients have been treated for more
than 1 year. Adverse events reported in ≥ 20% of patients in the CellCept
treatment groups are presented below.

The placebo-controlled renal
transplant study generally showed fewer adverse events occurring in ≥ 20%
of patients. In addition, those that occurred were not only qualitatively
similar to the azathioprine-controlled renal transplant studies, but also
occurred at lower rates, particularly for infection, leukopenia, hypertension,
diarrhea and respiratory infection.

The above data demonstrate that
in three controlled trials for prevention of renal rejection, patients
receiving 2 g/day of CellCept had an overall better safety profile than did
patients receiving 3 g/day of CellCept.

The above data demonstrate that
the types of adverse events observed in multicenter controlled trials in renal,
cardiac, and hepatic transplant patients are qualitatively similar except for
those that are unique to the specific organ involved.

Sepsis, which was generally CMV
viremia, was slightly more common in renal transplant patients treated with
CellCept compared to patients treated with azathioprine. The incidence of
sepsis was comparable in CellCept and in azathioprine-treated patients in
cardiac and hepatic studies.

In the digestive system,
diarrhea was increased in renal and cardiac transplant patients receiving
CellCept compared to patients receiving azathioprine, but was comparable in
hepatic transplant patients treated with CellCept or azathioprine.

Patients receiving CellCept
alone or as part of an immunosuppressive regimen are at increased risk of
developing lymphomas and other malignancies, particularly of the skin (see WARNINGS:
Lymphoma and Malignancy). The incidence of malignancies among the 1483
patients treated in controlled trials for the prevention of renal allograft
rejection who were followed for ≥ 1 year was similar to the incidence
reported in the literature for renal allograft recipients.

Lymphoproliferative disease or
lymphoma developed in 0.4% to 1% of patients receiving CellCept (2 g or 3 g
daily) with other immunosuppressive agents in controlled clinical trials of
renal, cardiac, and hepatic transplant patients followed for at least 1 year
(see WARNINGS: Lymphoma and Malignancy). Non-melanoma skin
carcinomas occurred in 1.6% to 4.2% of patients, other types of malignancy in
0.7% to 2.1% of patients.

Three-year safety data in renal and cardiac transplant
patients did not reveal any unexpected changes in incidence of malignancy
compared to the 1-year data.

In pediatric patients, no other malignancies besides
lymphoproliferative disorder (2/148 patients) have been observed.

Severe neutropenia (ANC < 0.5 x 103/μL)
developed in up to 2.0% of renal transplant patients, up to 2.8% of cardiac transplant
patients and up to 3.6% of hepatic transplant patients receiving CellCept 3 g
daily (seeWARNINGS: Neutropenia, PRECAUTIONS: Laboratory
Tests and DOSAGE AND ADMINISTRATION).

All transplant patients are at increased risk of
opportunistic infections. The risk increases with total immunosuppressive load
(see WARNINGS: Serious Infections and WARNINGS: New or
Reactivated Viral Infections). Table 10 shows the incidence of
opportunistic infections that occurred in the renal, cardiac, and hepatic
transplant populations in the azathioprine-controlled prevention trials:

In the placebo-controlled renal
transplant study, the same pattern of opportunistic infection was observed
compared to the azathioprine-controlled renal studies, with a notably lower
incidence of the following: Herpes simplex and CMV tissue-invasive disease.

In patients receiving CellCept
(2 g or 3 g) in controlled studies for prevention of renal, cardiac or hepatic
rejection, fatal infection/sepsis occurred in approximately 2% of renal and
cardiac patients and in 5% of hepatic patients (see WARNINGS: Serious
Infections). In cardiac transplant patients, the overall incidence
of opportunistic infections was approximately 10% higher in patients treated
with CellCept than in those receiving azathioprine, but this difference was not
associated with excess mortality due to infection/sepsis among patients treated
with CellCept.

The following adverse events
were reported with 3% to < 20% incidence in renal, cardiac, and hepatic
transplant patients treated with CellCept, in combination with cyclosporine and
corticosteroids.

Table 11 : Adverse Events
Reported in 3% to < 20% of Patients Treated With CellCept in Combination With
Cyclosporine and Corticosteroids

Pediatrics

The type and frequency of
adverse events in a clinical study in 100 pediatric patients 3 months to 18
years of age dosed with CellCept oral suspension 600 mg/m² bid (up
to 1 g bid) were generally similar to those observed in adult patients dosed
with CellCept capsules at a dose of 1 g bid with the exception of abdominal
pain, fever, infection, pain, sepsis, diarrhea, vomiting, pharyngitis,
respiratory tract infection, hypertension, leukopenia, and anemia, which were
observed in a higher proportion in pediatric patients.

CellCept Intravenous

The adverse event profile of CellCept Intravenous was
determined from a single, double-blind, controlled comparative study of the
safety of 2 g/day of intravenous and oral CellCept in renal transplant patients
in the immediate posttransplant period (administered for the first 5 days). The
potential venous irritation of CellCept Intravenous was evaluated by comparing
the adverse events attributable to peripheral venous infusion of CellCept
Intravenous with those observed in the intravenous placebo group; patients in
this group received active medication by the oral route.

Adverse events attributable to peripheral venous infusion
were phlebitis and thrombosis, both observed at 4% in patients treated with
CellCept Intravenous.

In the active controlled study in hepatic transplant
patients, 2 g/day of CellCept Intravenous were administered in the immediate
posttransplant period (up to 14 days). The safety profile of intravenous
CellCept was similar to that of intravenous azathioprine.

Postmarketing Experience

Congenital Disorders

Embryofetal Toxicity: Congenital malformations, including
ear, facial, cardiac and nervous system malformations and an increased
incidence of first trimester pregnancy loss have been reported following
exposure to mycophenolate mofetil during pregnancy (see PRECAUTIONS: Pregnancy).

Polyomavirus associated neuropathy (PVAN), especially due
to BK virus infection, has been observed in patients receiving
immunosuppressants, including CellCept. This infection is associated with
serious outcomes, including deteriorating renal function and renal graft loss.

Viral reactivation has been reported in patients infected
with HBV or HCV.